No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 120
Sex
Female
Study type
Observational
Participants needed
100 (estimated)
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NIH
Who this trial is looking for
This trial is looking for women under 40 with systemic lupus erythematosus starting treatment with cyclophosphamide. Participants will complete a 30-minute survey about their menstrual cycle and reproductive health, and researchers will review medical records.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman under 40 years old.
I have systemic lupus erythematosus.
I am starting treatment with cyclophosphamide.
You may not be able to join if
I am over 40 years old.
I have a history of reproductive disorders.
I have a history of infertility.
I have untreated sexually transmitted infections.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Background:
Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural hist…
Background:
Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not.
Objective:
To find out whether GnRHa can help protect women s ovaries during CYC.
Eligibility:
Women under age 40 years starting CYC treatment with or without GnRHa.
Design:
This study will do 2 things: It will conduct patient surveys. It will collect data from medical records.
Participants will complete a one-time survey. They will answer questions about their menstrual cycle. They will be asked about their history of pregnancy or infertility.
Participants can take the survey in 4 ways:
On paper, sent through the mail.
Online, in a secure web page managed by the NIH.
By phone.
In person, during a routine visit to the NIH clinic.
The survey will take about 30 minutes.
Participants medical records will be reviewed. Researchers will look for data about the participants SLE disease. This may include their symptoms and the results of their blood tests. It may also include the details of prior treatments.
Researchers will also collect data about participants reproductive history. This may include their personal or family history of infertility. It may include any fertility treatments and any sexually transmitted infections.
Trial Locations
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Eligibility Criteria
* ELIGIBILITY CRITERIA:
* INCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone
SLE females \<40 years at the beginning of CYC treatment without GnRH-a cotreatment.
-EXCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone
Females \>40 years at the beginning of CYC treatment; any fem…
* ELIGIBILITY CRITERIA:
* INCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone
SLE females \<40 years at the beginning of CYC treatment without GnRH-a cotreatment.
-EXCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone
Females \>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs).
-INCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months.
SLE females \<40 years at the beginning of CYC treatment with GnRH-a cotreatment.
-EXCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months.
Females \>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated STIs.
-Group: Control subjects.
Age-matched female SLE patients without a history of reproductive disorders, infertility, or untreated STIs, who have not received CYC either with or without GnRH-a.
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